Ruijian Medicine Launches Chengdu Headquarters and Partners with Danaher to Accelerate Clinical Translation of Novel Cell Therapies
iRegene Therapeutics
Cell Therapy Product Developer
'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
5Month28On [Date], iRegene's new headquarters in Chengdu officially began operations. The new address is located in Chengdu Tianfu International Bio City and has been established as iRegene's cell therapy drug research, development, and production base.
Figure: Ribbon Cutting
In recent years, Chengdu's biopharmaceutical industry has maintained rapid development. Based on comprehensive industrial support policies, a complete upstream and downstream industrial chain, supply chain network, and innovation ecosystem have been formed. Chengdu High-tech Zone also remains a leading biopharmaceutical industrial park in China.“First Tier”。
“Chengdu has given us ample space and necessary conditions to focus on refining our products. The new headquarters will further accelerate the industrialization and commercialization of the company's pipeline, laying a solid foundation for iRegene's future strategic development.”Founder of iRegene,CEODr. Wei Jun stated.
In addition, at the opening ceremony of iRegene's new headquarters in Chengdu on the same day, "iRegene-Danaher Joint Innovation Center" was also officially inaugurated. As the world's first“Joint Innovation Center for Chemical Induction Therapy and Microphysiological Systems”, the center will focus on artificial intelligence (AI) Driven by the deep integration of chemical-induced cell therapy research and microphysiological system technology, accelerating the clinical translation and application of innovative therapies to provide global patients with more precise and efficient disease treatment solutions.
Joining Hands with International Life Sciences Giant Danaher
Jointly Build a Disruptive Cell Drug R&D and Production Center
Figure: Danaher-iRegene Joint Innovation Center Signing
Currently, iRegene's core product for the treatment of Parkinson's diseaseNouvNeu001, has been2023Year8Monthly, approved by the National Medical Products Administration (NMPA) Approved to carry outI-IIA Phase Joint Clinical Study, Becoming the World's First Chemically-Induced Universal Cell Drug in the Parkinson's Field to Enter the Clinical Stage.2024Year6Month,NouvNeu001Once Again Obtained in the United StatesFDAClinical Approval Achieved in Both the U.S. and ChinaIND“Dual Filing and Dual Approval”. Currently, after administration12Months of ClinicalⅠThe phase data shows that the product has performed excellently in terms of safety and efficacy indicators, and has now entered clinical trials.ⅡPhase.
In addition, the company's second Parkinson's treatment productNouvNeu003In2023Year12Monthly Acquisition in ChinaNMPAApproved for clinical entry, currently also completedⅠAll subjects in the clinical trial have been enrolled and dosed. Ophthalmology productsNouvSight001In2024Year3Month Obtained in the United StatesFDAOrphan Drug Designation (ODD). At the same time, iRegene“Chemical Induction Platform”In2024Year3Month becomes the world's first to receive U.S.FDAR&D System with Special Exemption Qualifications.
Multiple advancements combined have made iRegene the leading company in the international pluripotent stem cell field, with the most regulatory approvals, the fastest pipeline progress, and the largest number of treated patients, drawing significant attention from numerous institutions. This year alone,4Month, iRegene has just completed nearly 100 million yuanB+Round of financing. Combined with the company's performance last year10Monthly completion exceeding 100 million yuanBIn this round of financing, the company has accumulated over2RMB 100 million, setting a record in ChinaiPSCRecord-high financing in the field.
"iRegene's'AI+"The 'chemical induction' platform will accelerate technological breakthroughs in the field of cell therapy, highly aligning with the key development track of cell and gene therapy in BioCity." A relevant official from Chengdu Tianfu International BioCity stated.
The official launch of the new headquarters in Chengdu also represents a further enhancement in iRegene's industrialization and commercialization capabilities. Dr. Wei Jun stated that currently, efforts are focused on...NouvNeu001Parkinson's Pipeline: iRegene Has Achieved Annual Production36With an annual production capacity of ten thousand doses, the production capacity will be further expanded after the Chengdu production base is put into use. "We will leverage our own advantages to strengthen cooperation with upstream and downstream sectors of Chengdu's biopharmaceutical industry, forming a globally leading cell therapy biotechnology company in Chengdu that is rooted in China and has a vision for the world."”
"The settlement of iRegene has injected new vitality and innovative momentum into the biocity. After more than eight years of development, the biocity now boasts complete industrial support, an excellent policy environment, and abundant talent resources, providing fertile ground full of opportunities and hope for the growth of iRegene," said Zheng Yubo, General Manager of Guosheng Capital.
"Chemical Induction+"Microphysiology"
Attempt to Crack the Clinical Translation Challenge
iRegene's New Headquarters in Chengdu not only supports the company’s industrialization and commercial development needs, but also hosts the joint establishment of "Danaher-The iRegene United Innovation Center will also commence operations at the new location.
As early as2022Year, iRegene and Danaher have already initiated cooperation to jointly build“iRegene-Danaher China Life Science Joint Laboratory”, Promoting Global Innovation Based onAIResearch and Clinical Application of Platform Chemical-Induced Cell Therapy. The establishment of this Joint Innovation Center marks a further upgrade in the cooperation between the two parties, creating the world's first "Joint Innovation Center for Chemical Induction Therapy and Microphysiological Systems."
According to the plan, the Joint Innovation Center will rely on iRegene's globally pioneering“AI+Chemical Induction”Platform, Microphysiological Systems (Microphysiological Systems, MPS) Original technical advantages, as well as Danaher's support in high-end instrument equipment, automation solutions, and global industrial resources, to build a full-chain R&D platform from target discovery to preclinical validation.
"Microphysiological systems are the core tool for the next generation of drug development. The deep collaboration with iRegene not only fills the technical gap between cell therapy and real human models but also will redefine the industry standards for precision medicine," said Hu Xiangyu, President of the Danaher Life Sciences Platform.
Specifically, the two parties will base their collaboration on “AI+"Chemical induction technology" to construct physiological models such as organoids and organ chips, simulating the human pathological microenvironment. Eventually forming "chemical induction+"Micro-physiological system" model to accelerate the evaluation of the efficacy and safety of cell therapies, thereby improving drug development efficiency and reducing the cost of new drug research. At the same time, integrate the equipment resources of Danaher to further promote the intelligence and scale of cell therapy processes.
iRegeneCEODr. Jun Wei stated:“This upgraded collaboration leverages the high-fidelity modeling advantages of organoid technology to drive chemical-induced cell therapy from foundational technological breakthroughs towards comprehensive, systematic innovation. Danaher's global resources and cutting-edge equipment will help us overcome treatment bottlenecks for complex diseases, benefiting more...'Incurable'Diseases Become History.”